Medical devices implanted without patients' consent.

Experimental medical devices were implanted by doctors in patients without the patient's knowledge or consent, according to a survey of hospitals across the country.

The findings, which were released in mid-April, were part of a government study ordered by the FDA. (June Gibbs Brown, Dep't of Health and Human Servs., Investigational Devices: Four Case Studies, No. OEI-05-94-00100 (Apr. 1995).) In the report, Inspector General June Gibbs Brown criticized some doctors for not fully following the informed consent process and for using the devices as if they had already been proven safe.

The study tracked the use of four medical devices used in surgery. Their use is supposed to be strictly monitored and is limited to research or to implementation only in a life-threatening emergency. (Tim Friend, Patients Not Told Devices Experimental, USA Today, Apr. 19, 1995, at 1A.)

The study found that doctors implanted the devices in many more patients than they reported to the FDA. At one hospital, a prosthetic device with a chemical coating to promote bone growth was implanted in 258 patients but was reported in only 37 surgeries, a violation of testing rules.

The study also monitored the use of an orthopedic device that promotes the growth of bone mass between two bones and an ophthalmic device used in eye surgeries. Patients receiving these implants were not always informed that they were experimental.

A fourth implant, a device used to treat urinary obstructions, also lacked oversight. One hospital report showed that no devices were implanted during the course of the study. But the implant's manufacturer reported that three devices had been implanted, one of which was inserted after the study date had closed, another violation of testing rules.

The FDA report did not identify the doctors or hospitals involved.

Gregory Ramirez, an attorney in Oxnard, California, who cochairs ATLA's Orthopedic Implants Litigation Group, said that although the report was written in "lightly worded, watered-down language," the implications are clear.

"The FDA has finally acknowledged that some doctors and hospitals are turning the other cheek to regulation," he said. "There is intentional concealment on their part, which amounts to collusion, because everyone involved--the doctors, the hospitals, the manufacturers--are making out like bandits monetarily from this deception."

Ramirez added that Congress has already passed legislation that expressly forbids experimental medical devices to be used for profit. "But the law is only as good as those who enforce it, and, clearly, nobody's doing that," he said.

Ramirez said his clients, many of whom have had similar medical devices implanted in their bodies without knowing that the devices were not approved, "are the victims in these cash cow merchandising operations.

"I have people in their mid-30s who are on morphine pumps. They can't pick up their kids and play with them, all as a result of experimental medical devices that failed. These people were lied to, plain and simple. They were told by their own doctors that the devices that were implanted in them had been approved by the FDA."

A copy of the report can be obtained by writing the Office of Inspector General, U.S. Department of Health and Human Services, 330 Independence Ave., S.W., Washington, DC 20201, or by calling [phone].